# LKG: Port & Catheter, Implanted, Subcutaneous, Intraventricular

- Device class: 2; regulation: 21 CFR 882.5550; FDA's rule: 510(k) required
- FDA decisions: 8
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1983: 1
- 1984: 2
- 1988: 4
- 1995: 1

## Most-cited predicates
- K874498: CSF-Ventriculostomy Reservoir (1988), cited by 2
- K874468: P-S Medical Ventricular Access Port (1988), cited by 1
- K833822: P-S Medical CSF Access Dev 15MM/25MM (1984), cited by 1

Source page: https://510kreport.com/product-code/LKG
Data by year (CSV): https://510kreport.com/product-code/LKG.csv